Summiting New Heights in the Mile-High City: Early Experiences, Strategies, and Solutions AAHRPP 2018 Annual Conference Agenda

Transcription

1 Friday, April 20, 2018 Pre- Workshop 7:00am 7:00pm Registration Attendee Registration 7:00am 8:00am Breakfast Continental Breakfast 8:00am 8:15am Welcome PC1 Welcome: Opening Elyse I. Summers, JD, AAHRPP 8:15am 8:30am Pre- PC2 Overview of AAHRPP Elyse I. Summers, JD, AAHRPP 8:30am 9:15am 9:15am 10:15am Pre- Pre- PC3 PC4 Accreditation Process: What to Expect When You re Expecting Accreditation Sarah H. Kiskaddon, JD, AAHRPP Kathleen Lawry, MSSA, AAHRPP Consultant Robert Withrow, AAHRPP How to Conduct the Self-Assessment Robert Frenck Jr., MD, Cincinnati Children s Hospital Medical Center Robert Hood, PhD, AAHRPP 10:15am 10:30am Break Break AM Break 10:30am 11:45am Pre- PC5 What to Expect During and After the Site Visit Monika Markowitz, PhD, MSN, Virginia Commonwealth University Michele Kennett, MSN, LLM, University of Missouri, Columbia 12:00pm 1:00pm Lunch Lunch Lunch

2 Friday, April 20, 2018 Pre- Workshop 1:00pm 3:15pm Pre- PC6 Review of Accreditation Standards Wesley G. Byerly, PharmD, University of Connecticut Kristin J. Craun, MPH, University of Southern California Russell Price, MArch, Utah State University (invited) 3:15pm 3:30pm Break Break PM Break 3:30pm 4:00pm Pre- PC7 Questions and Answers All Faculty 4:00pm Adjourn Adjourn

3 Saturday, April 21, 2018 Day 1 7:00am 4:45pm Registration Attendee Registration 7:30am 8:30am Breakfast Continental Breakfast 7:30am 5:00pm Exhibit Exhibitor Hours 8:00am 8:30am Welcome Opening W1 Welcome: Opening Ceremony Barbara Entwisle, PhD, University of North Carolina, Chapel Hill; Chair, Board of Directors, AAHRPP Elyse I. Summers, JD, AAHRPP 8:30am 10:00am Plenary P1 Informed Consent under the Revised Common Rule Jeremy Sugarman, MD, MPH, MA, Johns Hopkins Berman Institute of Bioethics 10:00am 10:30am Break AM Break 10:30am 11:45am A1 New Exemption Categories: Recalibrating the Approach to Low Risk Research Michele Russell-Einhorn JD, Shulman IRB David Borasky, MPH, WIRB-Copernicus Group A2 Top Ten Findings in AAHRPP Applications and Site Visits Robert Hood, PhD, AAHRPP Candice A. Yekel, MS, Pennsylvania State University

4 Saturday, April 21, 2018 Day 1 10:30am 11:45am A3 Quality Improvement and Quality Assurance: Successes and Innovations (Making the Most of Standard 1-5) K. Sue Haddock, PhD, RN, William Jennings Bryan Dorn VAMC Delia Wolf, MD, JD, Harvard School of Public Health A4 A5 Participant Centered Research: From Study Design to Return of Results Barbara E. Bierer, MD, Harvard Medical School, and Brigham and Women s Hospital (invited) Nanibaa A. Garrison, PhD, (invited) University of Washington, Seattle Children s Research Institute 11:45am 1:00pm Lunch Lunch Presentations of Certificates of Accreditation and Awards 1:00pm 2:15pm B1 Big Data and Confidentiality Elizabeth Buchanan, PhD, University of Wisconsin-Stout Laura M. Odwazny, MA, JD, DHHS (invited) B2 Single IRB Review: Are You Ready? Nichelle Cobb, PhD, University of Wisconsin-Madison, SMART IRB Megan Kasimatis Singleton, JD, MBE, Johns Hopkins School of Medicine

5 Saturday, April 21, 2018 Day 1 1:00pm 2:15pm B3 Exempt Research: Experiences and Solutions for Social Behavioral Research Russell Price, MArch, Utah State University (invited) Jodi Roberts, MA, Utah State University B4 2:30pm 3:45pm B5 C1 Learning from International Experiences with AAHRPP Site Visits John R. Baumann, PhD, Indiana University Ian Chen, MD, LLM, National Taiwan University Hospital, Taiwan Single IRB Review: Operational Solutions Martha F. Jones, MA, Washington University in St. Louis Megan Kasimatis Singleton, JD, MBE, Johns Hopkins School of Medicine C2 Vulnerable Populations: Overview and Updates Bruce Gordon, MD, University of Nebraska Medical Center Susan Kornetsky, MPH, Boston Children s Hospital C3 Defining Human Subject Research under the New Common Rule: Approaches to Initial HRPP Review Cynthia Gates, JD, RN, University of California, Davis Daniel Nelson, MS, US Environmental Protection Agency

6 Saturday, April 21, 2018 Day 1 2:30pm 3:45pm C4 C5 SACHRP Guidance and the New Rule Stephen Rosenfeld, MD, MBA, Quorum Review, Chair, SACHRP 3:45pm 4:00pm Break Break PM Break Visit Exhibitors and Poster Presentations 4:00pm 5:00pm Plenary P2 Examining the Potential and Challenges of Broad Consent Mark Barnes, JD, Ropes and Gray LLP, Multi-Regional Clinical Trials Center of Harvard and Brigham and Women s Hospital 5:00pm 6:30pm Social Social Social Hour/Visit Poster Presentation and Exhibits

7 Sunday, April 22, 2018 Day 2 7:00am 12:00pm Registration Attendee Registration 7:00am 8:00am Breakfast Continental Breakfast 7:00am 1:00pm Exhibit Exhibitor Hours 8:00am 9:00am Plenary P3 Achieving Health Equity: The Promise of Precision of Big Data Moderator: Barbara Entwisle, PhD, University of North Carolina, Chapel Hill Eliseo J. Pérez-Stable, MD, NIMHD 9:15am 10:30am D1 Continuing Review: Operationalizing the New Rule Wesley G. Byerly, PharmD, University of Connecticut Khemraj Hirani, PhD, PharmD, University of Miami D2 Meaningful Consent Forms: The Reasonable Person Standard Laura M. Odwazny, MA, JD, DHHS (invited) Jonathan M. Green, MD, Washington University in St. Louis (invited) D3

8 Sunday, April 22, 2018 Day 2 9:15am 10:30am D4 D5 Innovations and Strategies in Community Outreach Kaveh Khoshnood, PhD, MPH, Yale University (invited) Richard R. Sharp, PhD, Mayo Clinic 10:30am-10:45am Break AM Break Visit Exhibitors and Poster Presentations 10:45am-12:00pm E1 Reliance Agreements: Operational Strategies for Staffing, Verifying IRB Quality, and Comprehensive Templates Lauri Carlile, MS, Chesapeake IRB E2 Applying the Approval Criteria Consistently: Do It and Document It Robert Hood, PhD, AAHRPP Warren Capell, MD, University of Colorado, Denver E3 Privacy and Confidentiality in the New Era: Rethinking Consent Waivers Carol Weil, JD, National Cancer Institute E4

9 Sunday, April 22, 2018 Day 2 10:45am 12:00pm E5 New Consent Requirements Under the Common Rule Ivor Pritchard, PhD, OHRP (invited) Stephen Rosenfeld, MD, MBA, Quorum Review, Chair, SACHRP 12:00pm-1:00pm Lunch Networking Lunch FLEX Coalition & SMART IRB Lunch (pre-registration required) 1:00pm 2:00pm Plenary P4 Do New Tools Need New Ethics? The Challenge of Advancing Biotechnology for Ethics and Policy Jeffrey Kahn, PhD, MPH, Johns Hopkins Berman Institute of Bioethics 2:15pm- 3:30pm F1 The Expedited Review List: What Should be Included in the Revised Categories? (Participatory/Workshop Session) David Borasky, MPH, WIRB-Copernicus Group Ivor Pritchard, PhD, OHRP Michele Russell-Einhorn, JD, Shulman IRB F2 Implementing the NIH Policy on Certificates of Confidentiality John Heldens, BA, Univeristy of Colorado, Denver. F3 F4 F5 AAHRPP Update Michelle Feige, MSW, LCSW-C, AAHRPP Robert Hood, PhD, AAHRPP Elyse Summers, JD, AAHRPP 3:30pm Adjourn Adjourn